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Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

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Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Dear Editor

The BMJ under the editorship of Dr Godlee are to be commended for publishing important and concerning articles. In 2015 they published Restoring Study 329, which was also about clinical trial practices. The original study led to a fraud charge and a US Department of Justice action. While it reported efficacy that it did not find and hid serious safety problems, some of which remain concealed, that study was run to higher standards than the current vaccine trials. There was no Contract Research Organization (CRO) involved in Study 329.

In health we now have a clinical trial problem and it is difficult to see how we can put this right without insisting on access to trial data. We now have disputes about mandates with Daniel Sokol in BMJ recently among many who cannot see a case against them - what about No Mandates Without Data? We have a Pandemic of Overtreatment because hiding harms and hyping efficacy transforms the poisons from which we hope to bring good into sacraments. If our treatments work so well and are so free of harms, do we need expensive treatment dispensers?

Why would anyone want to see a doctor in person - if not for the ever fainter possibility they might meet someone willing to use a certain amount of discretion and stand by them if need be. Qualities Fiona Godlee has demonstrated during her tenure with BMJ.

Le Noury J, Nardo J, Healy D, Jureidini J, Raven M, Aba-Jaoude E, Tufanaru C (2015). Restoring Study 329: BMJ 2015; 351: h4320 | doi: 10 .113 6/bmj.h4320

Competing interests: No competing interests

25 November 2021
David Healy
Professor of Psychiatry
McMaster University
Hamilton, ON